Tampon insertion device

ABSTRACT

A tampon insertion device for inserting a tampon from a tampon applicator into a vaginal canal. The devices includes a hollow casing having an open distal end, a proximal end, a top wall extending between the proximal and distal ends, an open bottom opposing the top wall, and a clamp portion located at the distal end of the casing. The device further includes a plunger actuator located in the interior of the casing for linear movement therein, and a handle slidably positioned external to the casing and connected to the actuator such that linear sliding movement of the handle with respect to the casing causes a corresponding linear movement of the actuator within the casing. A method of inserting a tampon is also provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Non-Provisional patentapplication Ser. No. 16/416,216, filed on May 18, 2019, entitled “TAMPONINSERTION DEVICE,” and issued as U.S. Pat. No. 11,191,677. Thisapplication also claims priority to U.S. Provisional Patent ApplicationNo. 62/673,748, filed on May 18, 2018, entitled “TAMPON INSERTIONDEVICE.” The entire disclosures of the foregoing patent applications areincorporated by reference herein.

BACKGROUND

Tampons are the most commonly used feminine hygiene product because theyare discreet and comfortable. As opposed to bulky sanitary napkins,tampons provide a sense of cleanliness, discretion, and comfort duringmenstruation. Current tampons and tampon applicators require independentfinger strength and dexterity for proper insertion. The user must pinchthe applicator between two fingers, use forces to navigate theapplicator into the vagina, maintain the original pinch force whiledepressing the plunger to extrude the tampon into the body, use adexterous pinch grip again to remove the applicator from the body, andthen grasp and exert tension on the external string in order to removethe tampon from the body.

In particular, a conventional tampon/applicator assembly (40) is seen inFIGS. 7 and 9 herein. The tampon/applicator assembly (40) comprises atampon (42) (see FIG. 9) housed inside a hollow applicator barrel (44).A plunger (46) extends proximally away from the barrel (44), with thedistal end (48) of the plunger (46) located inside the barrel (44),abutting against the proximal end of the tampon (42) (see FIG. 9). Toinsert the tampon, the user must pinch the grip portion (50) of theapplicator barrel (44), insert the portion of the barrel (44) distal tothe grip portion (50) into her vaginal canal (while still pinching thegrip portion), and then push the plunger (46) distally into the barrel(while still pinching the grip portion) such that the tampon is expelledfrom the distal tip of the barrel (44) into her vaginal canal. The gripportion (50) must still be pinched by the user in order to remove theapplicator barrel (44) and plunger (46) from her vaginal canal, leavingthe tampon (42) in place.

This concentric cylinder tampon/applicator design actuated by dextroushand motion originated in 1933, see U.S. Pat. No. 1,926,900 (Catamenialdevice), and is still the predominant tampon insertion mechanism fortampon applicators used today. Current tampons fail to accommodate womenwith limited finger strength and/or dexterity.

While a variety of devices and techniques may exist for insertingtampons, it is believed that no one prior to the inventors has made orused an invention as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing outand distinctly claiming the invention, it is believed that the inventionwill be better understood from the detailed description of certainembodiments thereof when read in conjunction with the accompanyingdrawings. Unless the context indicates otherwise, like numerals are usedin the drawings to identify similar elements in the drawings. Inaddition, some of the figures may have been simplified by the omissionof certain elements in order to more clearly show other elements. Suchomissions are not necessarily indicative of the presence or absence ofparticular elements in any of the exemplary embodiments, except as maybe explicitly stated in the corresponding detailed description.

FIG. 1 depicts an orthogonal view of one embodiment of a tamponinsertion device, in the ready position primed for receiving atampon/applicator assembly therein.

FIG. 2 depicts a top view of the embodiment of FIG. 1.

FIG. 3 depicts a cross-sectional view of the embodiment of FIG. 1, takenalong the axis of actuation, which corresponds to the longitudinalcenterline of the casing (identified at 3-3 in FIG. 1).

FIG. 3A is the same view as FIG. 3, but with the handle and actuatoradvanced distally for expelling a tampon from an applicator barrel.

FIG. 4 depicts an exploded view of the embodiment of FIG. 1.

FIG. 5 depicts an enlarged view of the distal portion of the handle ofthe embodiment of FIG. 1.

FIG. 6 depicts an orthogonal view of the embodiment of FIG. 1, with anoff-the shelf tampon/applicator assembly clipped into the device and thehandle at its proximal position ready to expel the tampon from theapplicator.

FIG. 7 depicts an exploded side view of the embodiment of FIG. 6.

FIG. 8 depicts a bottom view of the embodiment of FIG. 6.

FIG. 9 depicts a cross-sectional view of the embodiment of FIG. 8, takenalong the axis of actuation (identified at 9-9 in FIG. 8).

FIG. 10 depicts the sequence of using the embodiment of FIG. 6 to inserta tampon into the body.

FIG. 11 depicts an alternate embodiment of a tampon insertion deviceaccording to the present disclosure.

FIG. 12 depicts yet another alternate embodiment of a tampon insertiondevice according to the present disclosure.

FIG. 13 depicts a front orthogonal view of another embodiment of atampon insertion device, in the ready position primed for receiving atampon/applicator assembly therein.

FIG. 14 depicts a rear orthogonal view of the embodiment of FIG. 13.

FIG. 15 depicts a bottom orthogonal view of the embodiment of FIG. 13.

FIGS. 16A and 16B depict side views of the embodiment of FIG. 13, withFIG. 16A showing the handle in its proximal (ready) position and FIG.16B showing the handle in its distal (deployed) position.

FIG. 17 depicts a front end view of the embodiment of FIG. 13.

FIG. 18 depicts a rear end view of the embodiment of FIG. 13.

FIG. 19 depicts a top view of the embodiment of FIG. 13.

FIG. 20 depicts an exploded view of the embodiment of FIG. 13.

FIG. 21 depicts an orthogonal view of the casing of the embodiment ofFIG. 13, and FIG. 21A depicts an enlarged view of the indicated portionof FIG. 21.

FIG. 22 depicts an orthogonal bottom view of the handle of theembodiment of FIG. 13, and FIG. 22A depicts an enlarged view of theindicated portion of FIG. 22.

FIG. 23 depicts an orthogonal view of an alternative embodiment of thecasing for use in the embodiment of FIG. 13.

FIG. 24 depicts a bottom orthogonal view of the casing of FIG. 23.

FIG. 25 depicts a pair of magnetically mountable clamp inserts for usewith the casing of FIG. 23.

FIG. 26 depicts an exploded front view of alternative embodiment of atampon insertion device according to the present disclosure.

FIG. 27 depicts a top orthogonal view of the assembled embodiment ofFIG. 26.

FIG. 28 depicts an exploded rear view of the embodiment of FIG. 26.

FIG. 29 depicts a side view of the embodiment of FIG. 26, with thehandle advanced distally for expelling a tampon from the barrel.

FIG. 30 depicts a bottom view of the embodiment of FIG. 29, with thelocation of the plunger inside the barrel also depicted in broken line.

The drawings are intended to illustrate rather than limit the scope ofthe present invention. Embodiments of the present invention may becarried out in ways not necessarily depicted in the drawings. Thus, thedrawings are intended to merely aid in the explanation of the invention.Thus, the present invention is not limited to the precise arrangementsshown in the drawings.

DETAILED DESCRIPTION

The following detailed description describes examples of embodiments ofthe invention solely for the purpose of enabling one of ordinary skillin the relevant art to make and use the invention. As such, the detaileddescription and illustration of these embodiments are purelyillustrative in nature and are in no way intended to limit the scope ofthe invention, or its protection, in any manner. It should also beunderstood that the drawings are not to scale and in certain instancesdetails have been omitted, which are not necessary for an understandingof the present invention.

Embodiments of the present disclosure provide an apparatus for insertingtampons, particularly an apparatus that facilitates tampon insertionwithout requiring independent finger strength or mobility. Moreparticularly, the present disclosure provides an apparatus for insertingtampons without requiring independent finger strength or mobility by useof a handle connected to an actuator that facilitates the dispensing atampon from its applicator as the handle is slid linearly along thecasing of the apparatus (e.g., along a linear rail on the top of thecasing).

The present disclosure is centered around an innovative mechanism forfacilitating tampon insertion without requiring finger strength ordexterity. Unlike conventional tampon insertion, embodiments of thepresent disclosure rely on increased actuating handle accessibility andless on finger strength and dexterity. As a result, individuals who havereduced finger strength and/or dexterity are better able to accomplishtampon insertion without (or with minimal) assistance.

Some embodiments of the present disclosure provide a reusable accessorythat clips onto a conventional tampon/applicator assembly and allows theuser to insert the cotton tampon from its applicator into the body usingarm motion, without requiring finger strength or dexterity. In oneparticular embodiment, the device has a casing having a U-shapedcross-section, wherein the casing is adapted to receive and retain anoff-the-shelf tampon/applicator assembly therein. A handle is configuredto slide along a linear rail defined by the top wall of the casing in adirection parallel to the tampon's line of action (i.e., the axis alongwhich the tampon is expelled from the barrel of the applicator). In oneembodiment, the handle is coupled to an actuator located inside thecasing, flush with the proximal and of the tampon plunger. The usergrasps or otherwise engages with the handle, secures the barrel of thetampon applicator in the casing (e.g., via an elastic clip or otherclamp) at an analogous location to where a user would conventionallypinch the applicator barrel, navigates the distal end of the barrel tothe vaginal opening and inserts the barrel into the vaginal canal up tothe front (i.e., distal) end of the apparatus (i.e., such that thedistal end of the casing does not enter the vaginal opening), andthereafter slides the handle in the direction of her body, resulting inthe dispensing of the tampon into the vaginal canal.

Other embodiments of the present disclosure are adapted for use ininserting a tampon that is not supplied with its own applicator (alsoknown as “digital tampons”). In these embodiments, the insertion deviceincludes a barrel (e.g., a reusable barrel) and a plunger actuated bythe slidable handle of the device. In some instances, the barrel isfastened to the distal end of the device, while in other instances thebarrel is removably attached to the device in a manner similar to theembodiment described above (e.g., using a clamp provided on the casing).

FIGS. 1 and 2 depict orthogonal and top views, respectively, of oneembodiment of a tampon insertion device (10) ready for insertion of atampon/applicator assembly therein. The tampon insertion device includesa hollow casing (also referred to as an applicator enclosure) (12)having an open distal (or front) end (14), a proximal (or back) end(16), a top wall that defines a linear rail (18), an open bottom (20) inopposition to the top wall (18), and a clamp portion (22) located at thedistal end of the casing (12). The casing thus defines a chamber (13)therein (see FIG. 3). A handle (24) is slidably positioned external tothe casing, and slides along the linear rail (18) of the casing (12) toexpel a tampon from an applicator retained within clamp portion (22).The linear rail (18) extends parallel to the axis of actuation of theapparatus, which coincides with the axis of the tampon applicatorplunger. In FIG. 1, the handle (24) is positioned at its most proximalposition (at the back of the linear rail (18) of the casing (12)).

The clamp portion (22) is configured such that a conventional tamponapplicator barrel can be snapped or clipped into the clamp portion (22).In the embodiment shown, the clamp portion (22) is U-shaped, and islocated so that the grip portion (50) of an applicator barrel (44) canbe clipped into the clamp (22). This allows the grip portion (50) to beused as a guide for clipping the tampon applicator (44) into the deviceat the proper location for aligning the proximal end (47) of theapplicator plunger (46) with the distal face (27) of the actuatorlocated within the casing chamber (13) (as further explained below). Thecompressible nature of the tampon applicator barrel (44) facilitatesclamping of the clamp portion (22) onto the barrel.

As best seen in the cross-sectional and exploded views of FIGS. 3 and 4,the tampon insertion device (10) further includes a plunger actuator(26) located inside the chamber (13) of the casing (12), with theactuator (26) mounted for linear movement therein (i.e., movement alongthe line of action of a tampon/applicator assembly clipped into theclamp portion (22)). The handle (24) is connected to the plungeractuator (26) such that linear movement of the handle with respect tothe casing (12) causes a corresponding linear movement of the actuator(26) within the chamber (13). In the particular embodiment depicted, thetop wall (18) of the casing (12) includes a void (28) (i.e., a slot)extending along a portion of the top wall (18), with the handle (24)connected to the actuator (26) through this void (28). It should benoted that the cross-section of FIG. 3 is taken along the centerline ofthe casing (12) in a plane which includes the axis (or line) ofactuation of the apparatus—i.e., the actuation plane along which thehandle (24) and actuator (26) are advanced in order to expel a tamponfrom an applicator barrel secured within the clamp (22) of the casing(12). This actuation plane also includes the axis of the tamponapplicator plunger, ensuring that the plunger is actuated linearly so asto smoothly expel a tampon from the applicator barrel.

The handle (24) can be connected to the plunger actuator (26) in avariety of ways. In the exemplary embodiment shown, the handle (24) isfastened to the plunger actuator (26) by way of an assembly dowel (30)extending downwardly from the handle (24), wherein the dowel (30) isreceived in a corresponding socket (32) provided in the actuator (26)(e.g., a snap fit between the dowel (30) and the socket (32)). Of coursea variety of other fastening mechanisms can be employed such as a screwor a nail or other complementary geometries being ultrasonically weldedor secured to one another using adhesive. The handle (24) and actuator(26) are assembled such that they reside on opposing sides of the topwall (18) of the casing. With the handle (24) and actuator (26)connected through the void (28), they form a subassembly that acts as asingle part such that exerting a linear actuating force on the handle(24) drives the actuation of the tampon applicator plunger (46) via theplunger actuator (26).

As best seen in the enlarged view of the distal (or front) portion ofthe handle (24) shown in FIG. 5, a linear rail guide (33) is provided onthe underside of the handle (24). In the exemplary embodiment, thelinear rail guide (33) is located adjacent the distal underside of thehandle (24), adjacent the dowel (30). It will be understood that theguide rail can be positioned at other locations on the underside of thehandle (24). The underside of the linear rail guide (33) has a shapethat is complimentary to the shape of the top of the casing (12), andserves to stabilize and guide the handle as it slides along the top wall(18) of the casing (12) and within the void (28). In particular, thelinear rail guide (33) includes an embossment (i.e., a projection) (34)that extends into the void (28) in the linear rail (18) of the casing(12) (see FIGS. 3 and 9). The undersides (35) of the rail guide (33)along opposite sides of the projection (34) are also shaped in a mannerthat compliments the shape of the top wall (18) of the casing (12), suchthat the rail guide (33) cradles a portion of the top wall (18) of thecasing with the projection (34) extending into the void (28). The linearrail guide's cohesive geometry facilitates smooth linear actuation asthe user guides the handle (24) along the linear rail (18) (i.e., thetop wall of the casing).

The tampon insertion apparatus depicted in FIGS. 1-6 further includes anenlarged flange portion (36) that extends laterally away from the opendistal end (14) of the casing (12). In the embodiment shown, theenlarged flange portion (36) comprises first and second rounded flanges(36A, 36B) that extend laterally away from opposite sides of the casingat the open distal end (14) thereof. The flange portion (36) increasesthe surface area at the distal end of the tampon insertion apparatussuch that the flange portion inhibits the distal (14) end of the casing(12) from entering the vaginal opening. The increased surface areaprovided by the flange portion (36), by not entering the vaginalopening, more efficiently facilitates an opposing normal force from thebody when the handle (24) is linearly urged towards the vagina duringuse. These opposite forces result in a dynamic system that allows thehandle (24) and plunger actuator (26) to be slid along opposite sides ofthe linear rail (18) towards the body while the flanged distal end ofthe casing remains relatively stationary.

With the device in the position shown in FIGS. 1-3, the user can clipthe applicator barrel (44) of a tampon/applicator assembly (40) into theclamp portion (22) by simply urging the grip portion (50) of theapplicator barrel into the chamber (13) of the casing. The clamp (22)and actuator (26) are configured such that, when the handle (24) is atits proximal, retracted position and the applicator barrel is properlyinserted into the clamp (12), the proximal end (47) of the plunger (46)will be positioned flush with the distal face (27) of the actuator (26),as seen in FIGS. 8 and 9. While the applicator barrel (44) can beclipped into the clamp portion (22) using two hands, the apparatus ofthe present disclosure is also advantageous in that this can beaccomplished using only one hand, without requiring finger strength ordexterity. In particular, a tampon/applicator assembly (40) can beplaced on an external surface and then, using the handle (24), theapparatus (10) is pressed over the applicator barrel (44) and plunger(46) such that the external surface on which the tampon/applicatorassembly (40) rests provides the normal force necessary to snap thebarrel (44) into the clamp (22). The tampon is clamped at a locationthat is identified in two ways. First, the clamped location is analogousto the grip location prescribed by the instructions for use of thetampon/applicator assembly. Second, the clamping location is the resultof aligning the proximal end (47) of the plunger flush with the distalface (27) of the actuator (26).

FIG. 10 depicts sequential views of the process of a user inserting atampon (42) into her vaginal canal using the tampon insertion device(10). With the tampon/applicator assembly (40) loaded in the device (10)(i.e., in the manner shown in FIG. 6), the user passes her hand throughthe loop-shaped handle (24) to allow the device (10) to be easilymanipulated. The user then navigates the device (10) and attachedtampon/applicator assembly (40) towards her vagina. She then inserts theexposed portion of the applicator barrel (44) into her vaginal canal,deep enough so that the contact flange (36) presses against tissueadjacent (and exterior to) the vaginal opening. Next, the user simplyslides the handle (24) towards her body, such as by using arm motiononly—movement of the fingers is not necessary. This results in thehandle (24) sliding distally along the linear rail (18) of the casing(12), since the flange portion (36) prevents distal movement of thecasing with respect to the vaginal canal. The contact flanges (36A, 36B)provide stability and increase surface area available to translate thenormal force provided by the body in the direction antiparallel to thedirection of action of the handle (24) and actuator (26). These opposingforces are static on the casing (12), but dynamic as the handle (24) hasfreedom to slide along the linear rail (18).

Because the handle (24) is fastened to the plunger actuator (26), whichis resting flush against the back of the applicator plunger (46), thedistal sliding of the handle (24) along the linear rail (18) urges theapplicator against the proximal end (47) of the applicator plunger (46)distally so as to push the tampon (42) out of the applicator barrel (44)through opening (45) at the distal end of the barrel and into thevaginal canal. At this point, the cotton tampon [28] is secured in thebody and no longer attached to its applicator or the tampon insertionaid. The device (10) can then be pulled away from the vagina and thetampon applicator barrel (44) unclipped from the device and theapplicator (44) and plunger (46) disposed of.

It should be noted that the distal movement of the handle is limited bythe length of the linear rail (18), particularly the void (28) therein.This prevents that actuator (26) from pushing the applicator barrel (44)out of the clamp (22). In addition, a lip or flange can be provided onthe proximal end of the barrel to provide a counter force on the clamp.This feature is further described in connection with the embodiment ofFIGS. 26-30.

While the handle (24) of FIGS. 1-9 is depicted as a linearly advancing,loop-shaped handle, the handle can be configured in a variety ofalternative ways intended to improve the ergonomics of devicemanipulation and/or actuation. For example, FIG. 11 depicts analternative embodiment of a tampon insertion device (110) wherein theloop-shaped handle (124) has been modified from that shown in FIGS. 1-9so as to include a single-finger loop (125) at the distal end of thehandle (124). This additional finger loop (125) can provide a morestable engagement of the handle (124) by the user's hand, therebyfacilitating distal advancement of the handle (124) with respect to thecasing. Of course one or more such finger loops can be provided, and canbe positioned at one or more locations along the handle.

In the alternative embodiment shown in FIG. 12, the handle (224) isrotatable such that the handle (224) can be at least partially rotatedto an orientation such that the length of the handle (224) is notparallel to the line of action of the device (however, the handle (224)is still linearly advanceable with respect to the casing along theactuation plane and the line of action). The rotating of the handle canbe provided, for example, by a rotatable connection between the handle(224) and the internal plunger actuator (e.g., such that the handlepivots about the axis of the connection between the handle and theactuator). This rotation allows the user to manipulate the handle from avariety of angles. In the alternative embodiments of FIGS. 13-30described below, the handle (324, 424, 524, 724) similarly can berotatably connected to the actuator (326, 426, 526, 726) and/or modifiedfor ergonomics (e.g., by the addition of one or more finger loops).

FIGS. 13-22 depict another alternative embodiment of a tampon insertiondevice (510) of the present disclosure, wherein the device (510) can beused in the same manner described above. The insertion device (510) issimilar to insertion device (10) of FIGS. 1-9, with the principledifferences being the configuration of the flange portion (536), theconfiguration of the clamp (522), the addition of a retention mechanismfor releasably retaining the handle (524) in its proximal (ready)position (see FIG. 13), and a string capture slot (560) on the casing(512). Thus, tampon insertion device (510) includes a hollow casing(512) having an open distal end (514), a proximal end (516), a top wallthat defines a linear rail (518), an open bottom (520) in opposition tothe top wall (518), and a clamp portion (522) located at the distal endof the casing (512). A handle (524) is slidably positioned external tothe casing, and slides along the linear rail (518) of the casing (512)to expel a tampon from an applicator retained within clamp portion(522). In FIG. 16A, the handle (524) is positioned at its most proximalposition, such that the device (510) is ready to be loaded with atampon/applicator assembly. In FIG. 16B, the handle (524) is positionedat its most distal position, for expelling a tampon from its applicatorbarrel.

In the embodiment of FIGS. 13-22, the clamp portion (522) is formed inthe distal end (514) of the casing (512). Similar to clamp (22), clamp(522) comprises a generally U-shaped passageway, having a diametersmaller than the width of the internal chamber (513) and sized andconfigured to provide an interference fit with a barrel (44) of a tamponapplicator. As best seen in FIG. 17, the clamp portion (522) is open atits bottom end so as to provide a clamp entrance (523), similar to claim22) of the previously described embodiment. In this instance, however,the clamp entrance (523) is chamfered such that the width of the clampentrance (523) increases in the downward direction (see FIG. 17). Thischamfered clamp entrance (523) facilitates the securement of a tamponapplicator barrel within the clamp portion (522), since this not onlypresents a larger entrance area but also a tapered wall that helps guidethe applicator barrel into the clamp portion (522) until the barrelsnaps into place past the rounded internal lips (522A) located at theupper extent of the clamp entrance (523).

The tampon insertion device of FIGS. 13-22 also includes a flangeportion (536) that extends laterally away from the open distal end (514)of the casing (512). In this embodiment, the flange portion (536) has alobed design that includes three rounded lobes (536A, 536B, 536C) thatextend laterally away from the distal end (514) about the circumferenceof the clamp portion (522). Thus, two of the flange lobes (536A, 536B)extend laterally away from opposite sides of the open distal end (514)and the third flange lobe (536C) extends upwardly away from the opendistal end, such that the flange portion (536) extends around thecircumference of the clamp portion (536). The addition of the thirdflange lobe (536C) that extends upwardly away from the distal endportion (514) further aids in aligning the applicator barrel at theproper angle with respect to the vaginal canal. In particular, the thirdflange lobe (536C) helps to ensure that the barrel is not tilteddownwardly with respect to the vaginal canal during use. Also, in theparticular arrangement shown the distal face of the flange portion (536)is orthogonal to the line of action of the device (i.e., orthogonal tothe actuation plane along which the handle (524) and actuator (526) areadvanced in order to expel a tampon from an applicator barrel securedwithin the clamp (522)). As before, the flange portion (536) increasesthe surface area at the distal end (514) of the casing (512) such thatthe flange portion inhibits the distal end (514) of the casing fromentering the vaginal opening, and also facilitates an opposing normalforce from the body when the handle (524) is linearly urged towards thevagina during use.

The proximal face (537) of the flange portion (536) is outwardly flared(i.e., trumpeted), as best seen in FIGS. 14 and 16A. This outwardflaring, particularly when combined with the tri-lobed flangearrangement, not only provides an aesthetically pleasing appearance(similar to a flower), but also allows the flange portion (536) toincrease in thickness towards the casing (512) without significantlyrestricting the distal travel of the loop-shaped handle (524). As seenin FIG. 16B, the curvature of the proximal face (537) of the flangeportion (536) generally corresponds to that of the lower distal end(525) of the handle (524), as seen in FIG. 16B, thereby increasing thedistal travel of the handle. In one embodiment, contact between thelower distal end (525) of the handle (524) and the proximal face (537)of the flange portion (536) serves to limit the forward (distal) travelof the handle for preventing the plunger actuator (526) from ejectingthe applicator barrel from the clamp member. In other embodiments, thelength of the slot (528) in the linear rail (518) of the casing can beselected so as to limit the forward travel of the handle. As yet anotheralternative, a structure within the chamber (513) (e.g., an internalwall or other projection) can be arranged so as to limit forwardmovement of the actuator (526).

Like the previously described embodiments, tampon insertion device (510)further includes a plunger actuator (526) located inside the chamber(513) of the casing (512), with the actuator (526) mounted for linearmovement therein (i.e., movement along the actuation plane and the lineof action of a tampon/applicator assembly clipped into the clamp portion(522)). The handle (524) is connected to the plunger actuator (526) suchthat linear movement of the handle with respect to the casing (512)causes a corresponding linear movement of the actuator (526) within thechamber (513). The top wall (518) of the casing (12) includes a void(528) (i.e., a slot) extending along a portion of the top wall (518),with the handle (524) connected to the actuator (526) through this void(528). The handle (524) is connected to the plunger actuator (526) by adowel (530) (in the form of an elongate projection) extending downwardlyfrom the handle (524), wherein the projection (530) is received andsecured in a corresponding socket (532) provided in the top surface ofthe actuator (526) (e.g., via a snap fit or one of the other mechanismspreviously described). The handle (524) and actuator (526) are assembledsuch that they reside on opposing sides of the top wall (518) of thecasing. When the handle (524) and actuator (526) are connected throughthe void (528), they form a subassembly that acts as a single part suchthat exerting a linear actuating force on the handle (524) drives theactuation of the tampon applicator plunger (46) via the plunger actuator(526).

As best seen in the enlarged view of the distal (or front) portion ofthe handle (524) shown in FIG. 22A, the embodiment of FIGS. 13-22 alsoincludes a linear rail guide in the form of a projection (534) thatextends downwardly away from the distal bottom surface of the handle(524). As before, the projection (534) is configured to extend into thevoid (528) in the linear rail (518) of the casing (512) in order toguide movement of the handle with respect to the linear rail (518). Ifdesired, the rail guide on the handle (524) can be further configuredsimilar to the rail guide of the previous embodiment (i.e., so as toinclude additional side projections that extend over portions of the topwall of the casing, as seen in FIG. 5).

The embodiment of FIGS. 13-22 further includes a slide retentionmechanism that retains the handle (524) (and hence the actuator (526))in its proximal, retracted position to facilitate tampon loading, whilestill allowing the handle to be advanced distally by the user. As bestseen in the enlarged view of FIG. 22A, a retention member (570) isprovided on the bottom surface of the handle (524) proximal to the guideprojection (534). The retention member (570) includes a first flatsection (572) that extends downwardly away from the bottom surface ofthe handle (524), and a deflection rib (574) immediately distal to thefirst section (572), wherein the deflection rib (574) extends downwardlyaway from the bottom surface of the handle (524) a greater extent thanthe first flat section (572) (i.e., the deflection rib (574) is greaterin height than the first flat section (572)). The deflection rib (574)is also spaced away from the proximal end (534A) of the guide projection(534) such that a gap (575) is provided therebetween.

The retention member (570) is configured to releasable engage with anengagement member. In this example, the engagement member comprises adeflectable, cantilevered beam (580) located at the proximal end of thevoid (i.e., slot) (528) in the top wall (518) of the casing (see FIGS.21 and 21A). As best seen in the enlarged view of FIG. 21A, the proximalend of the cantilevered beam (580) is fixed to the top wall (518) of thecasing (512), adjacent the proximal end of the casing. The sidewalls(582A, 582B) of the cantilevered beam (580) are spaced away from theinterior sidewalls of the void (528) such that the beam (580) isdeflectable downwardly into the slot (528). A locking rib (584) isprovided at the distal end of the cantilevered beam (580). As the handle(524) is slid proximally (i.e., from the position in FIG. 16B towardsthe position in FIG. 16A), the first flat section (572) of the retentionmember (570) on the handle will pass over the locking rib, causing thecantilevered beam (580) to deflect downwardly into the slot (528),thereby preloading the deflectable (i.e., flexible) beam (580). As thehandle (524) is further slid proximally, the deflection rib (574) willadvance over the locking rib (584) of the beam (580), causing the beamto deflect further downwardly. As the handle is slid even further in theproximal direction, the deflection rib (574) on the handle will movepast the locking rib (584), allowing the cantilevered beam (580) toreturn towards its undeflected position (FIG. 21). As a result, thelocking rib (584) will enter the gap (575) between the deflection rib(574) and the proximal end (534A) of the guide projection (534) on theunderside of the handle (524). As a result, the locking rib (584) willimpede distal movement of the handle (524) until sufficient force isapplied to the handle during use to allow the deflection rib (574) topass over the locking rib (584) by deflecting the beam (580) downwardlyinto the slot (528). As also seen in FIGS. 21A and 22A, the walls of thedeflection and locking ribs (574, 584) are angled in order to facilitatemovement past one another.

It will be understood that a variety of alternative forms of slideretention mechanisms can be used in place of the retention member andcantilevered beam arrangement. By way of example, one or more magneticregions can be provided on the casing and/or on the handle, along withcomplementary magnetic (i.e., opposite polarity) or ferrous regions onthe other of the handle and/or casing. These magnetic/ferrous regionsare located so as to retain the handle in its proximal position, whilestill allowing the handle to move distally when sufficient force isapplied thereto.

The embodiment of FIGS. 13-22 further includes a string capture slot(560) on the casing (512), which may be used to assist in removing atampon. In particular, tampon strings typically have a knot tied intothe free end of the string. While the string is used to remove a tamponfrom the vaginal canal, this may be difficult for somewomen—particularly if they have limited finger strength or dexterity.The string capture slot (560) on the insertion device (510) can be usedto capture the knot of the tampon string therein, thus allowing thedevice (510) to be used to pull the tampon out of the vaginal canal.

As best seen in FIG. 18, the string capture slot (560) is located in theproximal end wall of the casing (512) (although it could be locatedelsewhere on the device). The string capture slot (560) includes a firstportion (561) that extends upwardly from the bottom edge (563) of theproximal end of the casing (512), which terminates in a second portion(562). The first portion (561) of the capture slot tapers in widthtowards the second portion (562) of the slot, while the second portion(562) has a generally constant width that is less than that of a typicaltampon string knot but slightly larger than the typical width of theuntied string (e.g., about 2 to about 2.5 mm in width). To use thedevice (510) for tampon removal, the device is placed over the tamponstring such that the string moves into the capture slot (560) andbottoms out in the second portion (562) of the slot. The device is thenslid down the removal string until the knot I the string reaches theslot (560). The user can then simply pull the device away from thevaginal opening, causing the tampon removal string to be pulled awayfrom the user's vagina—thus removing the tampon.

While the tampon insertion device (10, 110, 210, 510) can bemanufactured in two or more configurations to accommodate sizedifferences in the applicator barrels of tampon/applicator assembliesfrom different manufacturers, FIGS. 23 and 24 depict an alternativeconfiguration of a casing (612) that may be used in place of casing(512) in the embodiment of FIGS. 13-22 (or in place of casing (712) inFIGS. 27-30). In this instance, the casing (612) is configured such thatthe clamp for securement of an applicator barrel within the casing isprovided a selected one of two or more clamp inserts (622A, 622B) ofdiffering sizes that are removably mountable within a clamp recess (690)formed in the distal end (614) of the casing (612). Each of the clampinserts (622A, 622B) is configured similar to clamp (522), comprising agenerally U-shaped passageway having a diameter smaller than the widthof the internal chamber (613) and sized and configured to provide aninterference fit with a barrel (44) of a tampon applicator. As seen inFIG. 25, the internal diameter of the clamp insert (622A) is larger thanthat of the clamp insert (622B), and therefore is used for applicatorshaving larger diameter barrels.

The external size and shape of the clamp inserts (622A, 622B) areidentical, and match that of the clamp recess (690) in the distal end ofthe casing (612). In the example shown, the clamp inserts (622A, 622B)and clamp recess (690) have a rectangular configuration such that eachof the clamp inserts (622A, 622B) can be selectively and matinglysecured within the clamp recess (690). It will be understood that theclamp inserts (622A, 622B) and clamp recess (690) can have any of avariety of other matching configurations such as square, polygonal,oval, circular, etc.

The clamp inserts (622A, 622B) and the clamp recess (690) includeretention features for releasably retaining a selected one of the clampinserts within the recess for use of the device. In the example shown,one or more magnets (691) are provided in or on the upper interior wallof the clamp recess (690) and corresponding magnets (692) of oppositepolarity to that of magnets (691) are provided in or on the upper wallof the clamp inserts (622A, 622B). In this manner, the magneticattraction between the aligned magnets (691, 692) will retain the clampinsert (622A, 622B) in place within the clamp recess (690) withsufficient force to allow use of the device, but still be removable sothat a different size clamp insert can be inserted into the clamp recess(690).

Alternatively, the retention features (e.g., magnets (691, 692) can beconfigured for permanent mounting of one of the clamp inserts (622A,622B) within the clamp recess (690). In this arrangement, the tamponinsertion device can be manufactured as a kit containing two or moresized of clamp inserts (622A, 622B), such that the end user can thenselect the appropriately sized clamp insert for permanent mountingwithin the clamp recess (690) based on her preferences.

It will also be understood that various other types of retentionmechanisms can be used to removably or permanently mount one of two ormore sizes of clamp inserts (622A, 622B) within the clamp recess (690).These retention mechanisms include, for example, hook-and-loopfasteners, or high friction surfaces on the engaging surfaces of clampinserts and the clamp recess.

Tampons are also available without an applicator (also known as “digitaltampons”). Such digital tampons typically comprise a cotton (or otherabsorbent material) tampon along with an attached string for removal ofthe tampon after use. Embodiments of the present disclosure areconfigured for aiding in the insertion of digital tampons, and one suchembodiment is depicted in FIGS. 26-30. In this embodiment, the tamponinsertion device (710) includes a casing (712) and a handle (724) thatare configured similar to the casing (512) and handle (524) in FIGS.13-22. Thus, the casing (712) includes a tri-lobed flange portion (736)that extends laterally away from the open distal end (714) of the casing(712). The hollow casing (712) once again defines an internal chamber(713) (see FIG. 30), as well as a top wall that defines a linear rail(718). The handle (724) is slidably positioned external to the casing,and slides along the linear rail (718) of the casing (712) to expel atampon from the distal end of the device. In FIG. 27, the handle (724)is positioned at its most proximal position, such that the device (710)is ready to be loaded with a tampon. In FIGS. 29 and 30, the handle(724) is positioned at its most distal position, for expelling a tamponfrom the distal end of the device (710).

As in the embodiment of FIGS. 13-22, a clamp portion (722) is formed inthe distal end (714) of the casing (712). Clamp (722) comprises agenerally U-shaped passageway, having a diameter smaller than the widthof the internal chamber (713) and is sized and configured to provide aninterference fit with a reusable barrel (744) (described below). Theclamp portion (722) is open at its bottom end so as to provide a clampentrance, similar to the clamp (522) of the previously describedembodiment.

In the embodiment of FIGS. 26-30, the handle (724) is connected to anactuator assembly (726) (further described below) by an elongateprojection (730) that extends downwardly from the handle (724), whereinthe projection (730) is received and secured in a corresponding socket(732) provided in the drive carriage (729) of the actuator assembly(726) (e.g., via a snap fit, adhesive, ultrasonic welding, or one of theother mechanisms previously described). The handle (724) and drivecarriage (729) are assembled such that they reside on opposing sides ofthe top wall (718) of the casing. With the handle (724) and drivecarriage (729) connected through the void (728), they form a subassemblythat acts as a single part such that exerting a linear actuating forceon the handle (724) drives the expelling of the tampon via the actuatorassembly (726).

As with the embodiment of FIGS. 13-22, a linear rail guide in the formof a projection (734) that extends downwardly away from the distalbottom surface of the handle (724) is provided, and is configured toextend into the void (728) in the linear rail (718) of the casing (712)in order to guide movement of the handle with respect to the linear rail(718). Thus, as in the previous embodiments, the projection (734) freelyslides within the void (i.e., slot) (728). If desired, the rail guide onthe handle (724) can be further configured similar to the rail guide ofthe embodiment of FIGS. 1-9. The embodiment of FIGS. 26-30 furtherincludes a slide retention mechanism for releasably retaining the handle(724) (and hence the actuator assembly (726)) in its proximal, retractedposition to facilitate tampon loading, while still allowing the handleto be advanced distally by the user. The slide retention mechanism inthis embodiment is configured identical to that of FIGS. 13-22, however,it will be understood that a variety of alternative mechanism can beemployed.

Since digital tampons are provided without an applicator barrel, thetampon insertion device (710) includes a reusable barrel (744) that isconfigured similar to that of a conventional tampon applicator. Itshould be noted that barrel (744) can also be configured to bedisposable, intended for a single use. In such instances, the barrel canbe sterile packaged to ensure sterility. For a reusable barrel (744),the barrel is preferably made of a suitable, biocompatible material thatcan be readily cleaned by the end user while providing sufficientstructural integrity for multiple used—e.g., biocompatible materialsthat can be cleaned and/or sanitized using, for example alcohol,antibacterial soaps or other disinfectants/sanitizers. Suitablematerials for the barrel (744) include, for example, medical gradesilicone, thermoplastic elastomers (e.g., Mediprene), and antimicrobialSanipolymers.

As best seen in FIGS. 26 and 28, barrel (744) is generally cylindrical,with an open proximal end (751), and a domed distal end wall (743)having an opening (745) through which a tampon can be expelled. Like aconventional tampon applicator barrel, the opening (745) in the distalend wall (743) of barrel (744) can be provided by an arrangement ofslits that meet at the distal tip of the barrel so as to form petals.Thus, when the distal end of a tampon is urged against the inner surfaceof the distal end wall (743), the opening (745) in the distal end wall(743) is forced open to allow the tampon to be expelled. In the depictedembodiment, the tampon barrel (744) is made of a biocompatible,resilient polymer that allows the opening (745) (i.e., the petals formedby the plurality of slits) to return to its closed position after atampon has been expelled therefrom.

A flange (750) is provided at the proximal end of the barrel (744). Theflange (750) not only serves as a guide for the insertion of the barrel(750) into the clamp portion (722) on the casing, it also helps toprevent the barrel (750) from being inadvertently pushed out of theclamp (722). As best seen in the bottom view of FIG. 30, the barrel isclipped into the clamp portion (722) such that the flange (750) islocated immediately proximate to the clamp (722) within the chamber(713). The diameter (D) (see FIG. 30) of the barrel (744) distal to theflange (750) is slightly larger than the inner diameter for the clampportion (722) such that the barrel is compressed slightly when clippedinto the clamp portion (722) to facilitate retention of the barrelwithin the clamp.

The actuator assembly (726) of the embodiment of FIGS. 26-30 includes adrive carriage (729) and an elongate plunger (731) extending distallyaway from the drive carriage (729). The drive carriage (729) can beconfigured similar to the actuator (526) of the previous embodiment,with its top surface (i.e., the surface in which the socket (732) isprovided) and its upper sidewalls (721) configured to match the shape ofthe interior walls of the chamber (713) of the casing (712) in order tofacilitate a smooth, linear motion of the drive carriage (729) withinthe casing. The elongate plunger (731) extends distally away from thedrive carriage, in alignment with the axis of actuation of the device(710). the plunger (731) may be integrally formed with the drivecarriage (729), or may be separately formed and attached thereto (e.g.,by adhesive or ultrasonic welding). The length and position of theplunger (731) and the travel of the drive carriage (729) and handle(724) are configured so that full distal travel of the handle (724)(FIG. 29) results in the distal end of the plunger (731) being drivensubstantially to the interior distal end of the barrel in order to fullyexpel a tampon from the distal end of the barrel.

To use the embodiment of FIGS. 26-30, a digital tampon is loaded intothe barrel (744) with the tampon string extending out the open proximalend (751) of the barrel. Next, with the device (710) in the positionshown in FIG. 27, the user clips the barrel (744) into the clamp portion(72) by simply urging the applicator barrel into the clamp with theflange (750) located inside the chamber (713) immediately proximal tothe clamp (722). At this point the loaded device (710) can be used toinsert the tampon into the vaginal canal in the manner describedprevious.ly. The handle (724) is slid distally along the linear rail(718) of the casing (712), resulting in linear movement of the plungeralong the central axis of the tampon (and the axis of actuation of thedevice) so as to expel the tampon into the vaginal canal. The barrel(744) can then be removed from the device (710) for cleaning and storagefor subsequent use.

The barrel can be provided with various features to facilitate properinsertion of the barrel (744) into the clamp (722), as well as toimprove the retention of the barrel within the clamp. For example, theexterior of the barrel at the intended clamping location can be textured(e.g., ribbed or other surface roughening) to improve grip within theclamp as well as by the user. The barrel can also be marked (e.g., astrip or other marking in a contrasting color) to identify the properclamping location. As an alternative to barrel (744) being loaded intothe casing (712) of the insertion device (710), it is also contemplatedthat the barrel can be fastened to the distal end of the device (eitherwithin the casing or fastened to the exterior of the casing).

The present invention has been described in terms of several particularembodiments and applications, both in summarized and detailed form.However, it is not intended that development of a tampon insertion aidis limited to the scope of these embodiments. It will be understood thatmany substitutions, changes and variations in the described embodiments,applications and details of the methods and components illustratedherein and of their operation can be made by those skilled in the artwithout departing from the spirit of this invention.

What is claimed is:
 1. A tampon insertion device for inserting a tamponfrom a tampon applicator into a vaginal canal, the tampon applicatorhaving a barrel containing a tampon and a plunger for expelling thetampon from the distal end of the barrel, said device comprising: (a) ahollow casing having an open distal end, a proximal end, a top wallextending between the proximal and distal ends, an open bottom opposingsaid top wall, and a clamp portion located at the distal end of thecasing; (b) a plunger actuator located in the interior of said casingfor linear movement therein; and (c) a handle slidably positionedexternal to said casing and connected to said actuator such that linearsliding movement of said handle with respect to said casing causes acorresponding linear movement of said actuator within the casing;wherein the interior of the casing is adapted to receive the tamponapplicator plunger and a portion of the tampon applicator barreltherein, through the open bottom of the casing, with said clamp portionretaining the tampon applicator barrel such that the distal end of thebarrel is spaced away from the distal end of, and external to, saidcasing with a proximal end of the plunger adjacent said actuator, suchthat linear movement of said handle in the direction of said distal endof the casing causes the tampon to be expelled from the distal end ofthe tampon applicator barrel while retaining the applicator barrel insaid clamp portion.
 2. The tampon insertion device of claim 1, whereinsaid actuator and said handle are linearly movable along an actuationplane that includes the centerline of the casing in order to expel atampon from an applicator barrel secured within the clamp.
 3. The tamponinsertion device of claim 2, further comprising an enlarged flangeportion extending laterally away from the distal end of said casing. 4.The tampon insertion device of claim 2, wherein the top of said casingdefines a linear rail having a void therethrough, said handle connectedto said actuator through said void, wherein said handle is configured toslide along said linear rail.
 5. The tampon insertion device of claim 1,wherein said clamp portion is configured to snap around a portion of theapplicator barrel so as to retain the applicator barrel therein.
 6. Thetampon insertion device of claim 5, wherein said clamp portion isU-shaped.
 7. The tampon insertion device of claim 2, wherein said handleis loop-shaped such that the user can insert her hand into theloop-shaped handle for manipulating the device.
 8. The tampon insertiondevice of claim 3, wherein said flange portion has a distal face that isorthogonal to said actuation plane, and a proximal face opposite thedistal face, wherein said proximal face is outwardly flared.
 9. Thetampon insertion device of claim 1, wherein said casing furthercomprises a string capture slot for capturing a tampon string tofacilitate removal of the tampon from a vaginal canal.
 10. The tamponinsertion device of claim 1, further comprising a slide retentionmechanism adapted to releasably retain the handle in a proximal,retracted position for facilitating tampon applicator loading.
 11. Thetampon insertion device of claim 10, wherein said slide retentionmechanism comprises a retention member on said handle and a cantileveredbeam on said casing, wherein said retention member is configured toreleasably engage said cantilevered beam.
 12. The tampon insertiondevice of claim 1, wherein said clamp portion comprises a clamp insertremovably mountable within a clamp recess formed in the distal end ofthe casing.
 13. A method of inserting a tampon into a user's vaginalcanal, comprising the steps of: (a) providing a tampon-loaded tamponinsertion assembly having a hollow casing having an open distal end, aproximal end, a top wall extending between the proximal and distal ends,and an open bottom opposing said top, a plunger positioned within thehollow casing, a barrel having an opening in its distal end throughwhich a tampon can be expelled, a proximal portion of the barrel securedto or within the hollow casing such that a distal portion of the barrelextends distally away from, and external to, the hollow casing, a handleslidably positioned external to the casing, and configured such thatlinear sliding movement of the handle with respect to the casing causesa corresponding linear movement of the plunger within the casing, and atampon positioned within the barrel; (b) inserting the distal portion ofthe barrel into the vaginal canal; and (c) sliding the handle of theinsertion device distally with respect to the casing and towards thevagina such that the plunger expels the tampon from the opening in thedistal end of the barrel and into the vaginal canal.
 14. The method ofclaim 13, wherein the insertion assembly further comprises a plungeractuator located in the interior of the casing for linear movementtherein, and further wherein the handle of the assembly is connected tothe actuator such that, when the handle is slid distally with respect tothe casing and towards the vagina, the actuator slides distally so as tourge the plunger distally and expel the tampon from the barrel and intothe vaginal canal.
 15. The method of claim 13, wherein the insertionassembly further comprises a drive carriage, wherein said plungerextends distally away from the drive carriage, said drive carriagelocated in the interior of the casing for linear movement therein, andfurther wherein the handle of the assembly is connected to the drivecarriage such that, when the handle is slid distally with respect to thecasing and towards the vagina, the drive carriage and plunger advancedistally such that the plunger expels the tampon from the barrel andinto the vaginal canal.
 16. The method of claim 14, wherein theinsertion assembly further comprises a clamp portion located at thedistal end of the casing, and said step of providing a tampon-loadedtampon insertion assembly comprises: providing an unloaded tamponinsertion device having said hollow casing, slidable handle and plungeractuator connected to said slidable handle; providing a tamponapplicator assembly having said barrel containing the tampon and theplunger extending proximally away from the barrel; and urging the tamponapplicator assembly into the hollow casing such that the clamp portionsnaps around the proximal portion of the barrel so as to retain theapplicator barrel therein, with the proximal end of the plungerpositioned adjacent the plunger actuator.
 17. The method of claim 16,wherein tampon insertion device further includes an enlarged flangeportion extending laterally away from the distal end of the casing, andfurther wherein the step of inserting the distal portion of the barrelinto the vaginal canal comprises inserting the distal portion of thebarrel is inserted into the vaginal canal until the enlarged flangeportion prevents further penetration of the vaginal canal.
 18. Themethod of claim 17, wherein the step of sliding the handle of theinsertion device distally with respect to the casing and towards thevagina comprises urging the handle towards the vagina against the normalforce provided by the contact between the enlarged flange portion andthe user's body.
 19. The method of claim 18, further comprising the stepof the user inserting her hand into the handle prior to inserting thedistal portion of the barrel into the vaginal canal.
 20. The method ofclaim 19, wherein said step of sliding the handle of the insertiondevice distally with respect to the casing and towards the vaginacomprises the user moving her arm towards her vagina.